- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00740662
Intraoperative Measuring of Small Bowel Length Compared to Measuring by Magnetic Resonance Imaging (MRI) in Morbid Obese Patients
Prospective Study for the Quantification of a Compensatory Increase in Small Bowel Length After Roux-en-Y Gastric Bypass in Morbid Obese Patients by Pre- and Postoperative Length-Measuring With MRI Compared to Intraoperative Length-Measuring
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Background:
An important step during a gastric bypass operation for the treatment of morbid obesity is the measuring of the small bowel length in order to define the lengths of the alimentary, biliopancreatic and common channel. The measuring itself is technically simple but has always an error due to the variable state of contraction of the small bowel. In distal gastric bypass a common channel length of 100 to 150 cm is chosen which induces an iatrogenic short bowel syndrome. At several reoperations we found a length increase of the common channel of up to 80% compared to the measured length at the initial operation. Former studies seem to indicate that an adaptation of small bowel length may occur in animals with short bowel syndrome or after intestinal bypass surgery. Longterm results of gastric bypass surgery often show weight regain after 3 to 5 years which could be due to the afore mentioned compensatory mechanism.
Newer MRI protocols allow for non-invasive measurement of the small bowel length. Comparing the preoperative and later on several postoperative measurements by MRI with the initial intraoperative length measuring should allow to validate the new MRI protocol and in the same time quantify the eventual small bowel length increase.
Objective:
In-vivo verification of small bowel length measurements made by MRI, quantification of a possible increase of the common channel length in the long run after distal gastric bypass.
Methods:
The preoperative small bowel length measurement by MRI is compared to the length measured intraoperatively. MRIs before discharge postoperatively as well as after 6 and 12 months are used to detect an eventual increase of the common channel length.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Bern, Schweiz, 3010
- Department of Visceral and Transplantsurgery, Bern University Hopsital
-
Bern, Schweiz, 3010
- Institute of diagnostic, interventional and pediatric Radiology, Bern University Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- morbid obese patient
- scheduled for distal gastric bypass
- informed consent for operation and study obtained
Exclusion Criteria:
- history of former small bowel resection
- weight > 150 kg
- history of claustrophobia
- general contraindications for MRI (pacer, joint prosthesis, ear implant, etc.)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
1
Distal gastric bypass
|
Distal gastric bypass
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Small bowel length in vivo compared to measurements by MRI
Tidsramme: preoperative, previous to hospital discharge, 6 and 12 months postoperative
|
preoperative, previous to hospital discharge, 6 and 12 months postoperative
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Compensatory increase of the common channel (small bowel) after distal bypass
Tidsramme: 12 months postoperative
|
12 months postoperative
|
|
Correlation of longterm weight regain with increase of common channel length
Tidsramme: 12 months postoperative
|
12 months postoperative
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Jean-Marc Heinicke, MD, Department of Visceral and Transplant Surgery, Bern University Hospital
- Ledende efterforsker: Philipp C Nett, Dr, DRNN, Inselspital, Bern University Hospital, Switzerland
Publikationer og nyttige links
Generelle publikationer
- Miskowiak J, Andersen B. Intestinal adaptation after jejunoileal bypass for morbid obesity: a possible explanation for inadequate weight loss. Br J Surg. 1983 Jan;70(1):27-8. doi: 10.1002/bjs.1800700110.
- Swaniker F, Guo W, Fonkalsrud EW, Brown T, Newman L, Ament M. Adaptation of rabbit small intestinal brush-border membrane enzymes after extensive bowel resection. J Pediatr Surg. 1995 Jul;30(7):1000-2; discussion 1003. doi: 10.1016/0022-3468(95)90329-1.
- Hughes CA, Ducker DA. Adaptation of the small intestine--does it occur in man? Scand J Gastroenterol Suppl. 1982;74:149-58.
- Wyss M, Froehlich JM, Patak MA, Juli CF, Scheidegger MB, Zollikofer CL, Wentz KU. Gradient-enhanced volume rendering: an image processing strategy to facilitate whole small bowel imaging with MRI. Eur Radiol. 2007 Apr;17(4):1081-8. doi: 10.1007/s00330-006-0472-2. Epub 2006 Oct 5.
- Patak MA, Froehlich JM, von Weymarn C, Breitenstein S, Zollikofer CL, Wentz KU. Non-invasive measurement of small-bowel motility by MRI after abdominal surgery. Gut. 2007 Jul;56(7):1023-5. doi: 10.1136/gut.2007.120816. No abstract available.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KEK248_07
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Distal gastric bypass
-
Ain Shams UniversitySuspenderet
-
University of Roma La SapienzaAfsluttet
-
Spital Limmattal SchlierenUkendtFedme | Bypass komplikationerSchweiz
-
Medical University of ViennaUkendt
-
Federal University of PiauiIkke rekrutterer endnuDiabetisk perifer neuropati
-
Nemocnice Břeclav, p.o.UkendtDiabetes mellitus, type 2 | Fedme, sværTjekkiet
-
Technische Universität DresdenTrukket tilbageBugspytkirteltumorTyskland
-
National Cancer Center, KoreaUkendt
-
Federal University of PiauiIkke rekrutterer endnuDiabetisk perifer neuropati
-
Kular HospitalAfsluttetFedme | Sygelig fedme | Fedmekirurgiskandidat | Kostvane | Udvalg af madIndien